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HUBI BPHSCREEN - COFEPRIS Registration 1968R2021 SSA

Access comprehensive regulatory information for HUBI BPHSCREEN (HUBI BPHSCREEN) in the Mexico medical device market through Pure Global AI's free database. This Clase I medical device is registered under COFEPRIS analysis ID 1968R2021 SSA and manufactured by KABLACOMERCIAL,S.A.DE C.V.. The device was registered on November 25, 2021.

This page provides complete registration details including product type (III. DIAGNOSTIC AGENTS), manufacturer information, and regulatory compliance data from the official Mexico COFEPRIS medical device database. Pure Global AI offers free access to Mexico's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate COFEPRIS regulations efficiently.

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COFEPRIS Official Data
Clase I
1968R2021 SSA
HUBI BPHSCREEN
COFEPRIS Analysis ID: 1968R2021 SSA
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Product Use / Uso del Producto
Spanish

ES UNA PRUEBA PARA LA DETERMINACIร“NCUANTITATIVADEPSALIBRE,PSATOTALYLARELACIร“N DE PSA LIBRE Y PSA TOTAL ENSANGRE HUMANA ENTERA.

English

IT IS A TEST FOR THE QUANTITATIVE DETERMINATION OF FREE PSA, TOTAL PSA AND THE RATIO OF FREE PSA AND TOTAL PSA IN WHOLE HUMAN BLOOD.

Device Classification
Risk Class / Clase de Riesgo
Clase I
Product Type (Spanish)
III. AGENTES DE DIAGNร“STICO
Product Type (English)
III. DIAGNOSTIC AGENTS
Trade Name (Spanish)
PRUEBA PARA DETERMINACIร“N DE PSALIBRE/TOTAL
Trade Name (English)
TEST FOR DETERMINATION OF PSALIBRE/TOTAL
Registration Information
Analysis ID
1968R2021 SSA
Registration Date
November 25, 2021
Manufacturer / Fabricante
Name (English)
KABLACOMERCIAL,S.A.DE C.V.